BridgeMD
New treatment option for Advanced Solid Tumor
Official title First-in-Human Study of DS-3939a in Participants With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT05875168
What this study is testing
What is DS-3939a?
DS-3939a is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will evaluate the safety, tolerability, and efficacy of DS-3939a in participants with advanced solid tumors.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Sign and date the main Informed Consent Form (ICF).
- Has a left ventricular ejection fraction ≥50% by either an echocardiogram or multigated acquisition within 28 days of enrollment.
- Has adequate organ function.
- Measurable disease based on RECIST V1.1.
- Eastern Cooperative Oncology Group performance status score of 0 or 1. Additional for Part 1
You likely can't join if
- Has had prior treatment targeting mucin 1 (MUC1) or TA-MUC1.
- Has spinal cord compression or clinically active central nervous system metastases.
- Has multiple primary malignancies, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors...
- Has any history of ILD/pneumonitis irrespective of steroid use, or current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at...
- Has active or uncontrolled human immunodeficiency virus (HIV) infection.
- Has evidence of active or uncontrolled hepatitis B virus or hepatitis C virus infection.
See the full eligibility criteria
- Sign and date the main Informed Consent Form (ICF).
- Has a left ventricular ejection fraction ≥50% by either an echocardiogram or multigated acquisition within 28 days of enrollment.
- Has adequate organ function.
- Measurable disease based on RECIST V1.1.
- Eastern Cooperative Oncology Group performance status score of 0 or 1. Additional for Part 1
- Has a histologically or cytologically documented locally advanced, metastatic, or unresectable solid malignant tumors. Additional for Part 2
- Has a histologically or cytologically documented locally advanced, metastatic, or unresectable cancer meeting the protocol criteria
- Is able to provide either of the following baseline tumor samples:
- Fresh tumor biopsy samples meeting either of the following requirements that were obtained during the Main Screening or Tissue Screening Period, or
- Fresh core needle biopsy sample
- Fresh biopsy samples obtained with forceps or cryobiopsy, such as bronchoscopic or transbronchial lung biopsy, or other procedures as long as the sample amount is equivalent to core needle biopsy and processing after...
- FFPE tumor tissue samples obtained by biopsy or surgery performed within 6 months before signing the main ICF. If samples were obtained prior to the start of the most recent anticancer therapy, the Sponsor Medical...
- Has had prior treatment targeting mucin 1 (MUC1) or TA-MUC1.
- Has spinal cord compression or clinically active central nervous system metastases.
- Has multiple primary malignancies, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated, with no evidence of disease for ≥3 years.
- Has any history of ILD/pneumonitis irrespective of steroid use, or current ILD, or suspected ILD, or ILD that cannot be ruled out by imaging at Screening. Participants may be eligible if they had history of radiation...
- Has active or uncontrolled human immunodeficiency virus (HIV) infection.
- Has evidence of active or uncontrolled hepatitis B virus or hepatitis C virus infection.
- Any of the following within the past 6 months: cerebrovascular accident, transient ischemic attack, or other arterial thromboembolic event.
- Has an active (ie, symptomatic and/or on-treatment), known, or suspected autoimmune disease.
- Current participation in other therapeutic investigational procedures, except for participation in Long Term Follow-Up without any investigational treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Sarasota, Florida, United States
- Portland, Oregon, United States
- Providence, Rhode Island, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
- Milwaukee, Wisconsin, United States
- Leuven, Belgium
- Montreal, Canada
- Toronto, Canada
- Beijing, China
- Jinan, China
- Neijiang, China
- Shanghai, China
- Lyon, France
- Marseille, France
- Strasbourg, France
- Toulouse, France
- Villejuif, France
- Chūōku, Japan
- Hirakata-shi, Japan
+ 9 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sarasota, Florida, United States; Portland, Oregon, United States; Providence, Rhode Island, United States; Houston, Texas, United States; Salt Lake City, Utah, United States; Milwaukee, Wisconsin, United States and 23 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.